MAUDE Adverse Event Report: OM HALYARD, INC. HALYARD; GOWN, SURGICAL

Model Number	44673
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Insect found inside the sterile package.

• Brand Name: HALYARD
• Common Device Name: GOWN, SURGICAL
• Manufacturer (Section D): OM HALYARD, INC.; 9120 lockwood blvd; mechanicsville VA 23116
• MDR Report Key: 16459769
• Report Number: 16459769
• Device Sequence Number: 15067465
• Product Code: FYA
• UDI-Device Identifier: 10680651446739
• UDI-Public: (01)10680651446739(17)270926(10)AH2269TFG
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/31/2023
• Report Date (Section F): 01/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 44673
• Device Catalogue Number: 44673
• Device Lot Number: AH2269TFG
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/01/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/01/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/31/2023